Compliance Readiness Quality Assurance

Compliance Readiness Quality Assurance

Abbott Laboratories | Minneapolis, MN, 55415, US
Salary Range:$82,000 – $114,000 Salary range estimated by Zippia

Posted 5 days ago

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About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.

What You'll Work On:

Divisional Strategic Inspection/Audit Support Management

* Reporting to the QA Manager Strategic Readiness, supports regional program for inspections/audit readiness. Establishes and maintain divisional procedural requirements for external audit support and processing.

* Utilizes ANQA strategic direction and data to develop audit readiness strategies, communication plan etc. per site as audit preparation. With sites, prepare audit preparation plans and assist in execution of the plans.

* Work with the sites and other functional groups to determine best in class replication opportunities within the Quality systems. Partner with the sites through assessments and simulations to determine and mitigate areas of high risks.

* Assists the sites, in coordination with quality system owners, in remediating and establishing action plans on critical and major audit findings.

* Overall responsibility is to assure that the AN global Quality system is effective in accordance with FDA, ISO and country specific requirements as well as AQR global policies.

* Assists in assuring that Quality System Owner Program and corresponding cadence of governance are established and effective in assuring robust quality system impact assessment to mitigate recurrence of compliance and product risk.

* Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

* Assists in reviewing Global Quality System health for improvements and opportunities. Develop insights, short term, and long-term goals to sustain Quality system health improvements.

* Assists in onboarding new Quality System Owners and Compliance Officers.

* Liaises with interdivisional team in external audit community of practice and manage external audit lifecycles with AQR to close all audits.

* Assists with food facility registrations and work with Regulatory Affairs and sites to ensure registration submissions are timely and accurate.



* Education: Bachelor's degree in applied, physical, or life science, engineering or business. Master's degree preferred.

* A minimum of 5 years of experience in Quality, Research and Development (R&D), Supply Chain and Manufacturing, regulatory and quality audits/inspections, or related experience is required. Experience working with sites, R&D, supplier, TPM, regulatory and affiliates is preferred.

* Ability to travel approximately 50%, including internationally.


* Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience.

* Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP)

* Expert knowledge of quality management systems and regulatory requirements.

* This position requires excellent problem solving and decision-making skills since the technology for many of Abbott's products are unique.

* This position requires a thorough understanding of integrated processes and technologies involved in supply management is required.

* The post holder must have the ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making. The post holder must have the ability to summarize and present technical recommendations and solutions to Abbott senior management

* Able to effectively manage project resources and stakeholder management

* High customer orientation and sense of ownership and strong focus on business outcomes

* Able to make decisions that impact project level activities and influence project level budget

* Able to interact and contribute effectively with others in a team

* Possess excellent communication and interpersonal skills

* Proficient in MS Office such as Outlook, Word, Excel, PowerPoint, Power Bi.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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